In order to make the activities of all the subordinate offices under the control of the Drugs Controller General India (DCGI) uniform and all activities require to be implemented in a rational way so that the whole system functions transparently, the DCGI has issued guidance document detailing about functions & responsibilities of zonal, sub-zonal and port offices of the Central Drugs Standard Control Organization (CDSCO).
These guidelines are intended for the guidance of departmental offices only. It sets out the nature of work that the zonal, sub-zonal and port offices of the CDSCO generally carry out and the guidelines about the policy that should be followed in disposing of the work and duties. However, these guidelines are not to be quoted as a reference in any official communication, except in the communications with the headquarters. The procedure set out therein cannot also be quoted as legal authority. While all conceivable item of work that pass through the CDSCO at the zone, sub-zone and ports have been included in these guidelines, there may be certain omissions.
This 483-page long document is in consonance with the objective of the Drugs & Cosmetic Act 1940 and Rules 1945 and other functions of CDSCO wherever applicable.
As per the guidelines, the broad functions & activities of zonal & sub zonal offices include, To participate in the joint inspection for issuance/revalidation of Certificate of Pharmaceutical Products (COPPs) as per WHO certification scheme after receiving the application from the manufacturing firm; To participate in the joint inspection for grant/renewal of blood bank license; To participate in the joint inspection for grant/renewal of license for vaccine / sera manufacturing units for both human as well as veterinary, To participate in the joint inspection for grant/renewal of license for LVP manufacturing units; To participate in the joint inspection for grant/renewal of license for notified medical devices & critical diagnostics manufacturing units; and also To participate in the joint inspection for grant/renewal of license for bio-tech & bio-similar products manufacturing units.
Other functions & activities of zonal & sub zonal offices include, To participate in the inspection of clinical trial facilities and BA/BE centres as directed by the DCGI from time to time; To carry out Surprise check/raid jointly/independently on the basis of complaint received under Whistle Blower scheme and also from other sources; To carry out joint inspection of drug testing laboratory for the purpose of grant of approval for test / analysis of drugs & cosmetics; To follow up action on NSQ drugs with State Licensing Authorities in the respective zone as well as with other zonal offices; Drawing of regular drug samples from the manufacturing & sales/distribution premises including the government establishment; When the samples drawn by the Central Drugs Inspector are declared spurious/adulterated/grossly substandard etc., the cases are investigated and prosecution are launched in the appropriate court after obtaining necessary sanction from the DCGI; Information regarding cancellation/suspension of manufacture licenses or withdrawal of product permission by the State Licensing Authority is circulated to other State Licensing Authorities in the zone and other zonal offices; and Deputation of drugs samplers at various places of suspicious nature and collect samples through them as surrogate patient from the sales premises by way of survey to monitor the quality of drugs. Further surprise check/raid is to be carried out by the Drugs Inspectors in case these samples are declared as NSQ by the testing lab.
According to the document, other broad functions & activities of zonal & sub zonal offices include, To pursue the court cases pending in different courts under the zone; Technical survey as and when directed by the DCGI from time to time; To coordinate with the medical colleges under PvPI falling under the zone in respect of their activities related to PvPI as directed by DCGI; To discuss the matter with various State Drugs Controllers in the zone in connection with enforcement of the provisions of D&C Act & Rules thereunder from time to time; To monitor the statutory work of Drugs Inspector working under the zonal and sub-zonal offices; and To co-ordinate for answering the Parliament Questions and for obtaining the data from various State Licensing Authorities under the zone.